EP4393434A1 - Korbkatheter mit einer kombination aus wirbelsäulenstrukturen - Google Patents

Korbkatheter mit einer kombination aus wirbelsäulenstrukturen Download PDF

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Publication number
EP4393434A1
EP4393434A1 EP23219842.4A EP23219842A EP4393434A1 EP 4393434 A1 EP4393434 A1 EP 4393434A1 EP 23219842 A EP23219842 A EP 23219842A EP 4393434 A1 EP4393434 A1 EP 4393434A1
Authority
EP
European Patent Office
Prior art keywords
spines
distal
end effector
spine
hub
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23219842.4A
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English (en)
French (fr)
Inventor
Paul Suarez
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biosense Webster Israel Ltd
Original Assignee
Biosense Webster Israel Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biosense Webster Israel Ltd filed Critical Biosense Webster Israel Ltd
Publication of EP4393434A1 publication Critical patent/EP4393434A1/de
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6858—Catheters with a distal basket, e.g. expandable basket
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6859—Catheters with multiple distal splines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/0016—Energy applicators arranged in a two- or three dimensional array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/00267—Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1475—Electrodes retractable in or deployable from a housing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1497—Electrodes covering only part of the probe circumference

Definitions

  • the present disclosure relates to a catheter for use in the vessel of a patient for the purpose of diagnosing or treating the patient, such as mapping tissue and/or ablating tissue using radio frequency (RF), irreversible electroporation (IRE), or other sources of energy.
  • RF radio frequency
  • IRE irreversible electroporation
  • Cardiac arrythmias are characterized as phenomenon that occurs when regions of cardiac tissue abnormally conduct electric signals to adjacent tissue.
  • cardiac arrythmias can include but not be limited to atrial fibrillation, supraventricular tachyarrhythmias, and the like. Resultantly, this phenomenon can disrupt the normal cardiac cycle, thus causing asynchronous cardiac cycles or rhythms.
  • the source of the undesired conduction of adjacent cardiac tissue can be attributed to tissue disposed in either an atria or a ventricle. Consequently, if the cardiac arrythmia remains unresolved, the unwanted signals can proliferate through the cardiac tissue, which can result in continued initiation or persistence of arrythmias.
  • Medical procedures to treat cardiac arrythmias generally include two steps: (1) mapping the electrical properties of the endocardium; and (2) selectively ablating cardiac tissue based on the mapped endocardium.
  • electrical activity can be measured at specific locations in the heart, which can be performed by advancing a catheter containing one or more electrical sensors into the heart to acquire the electrical activity data. Once the electrical data is obtained, the practitioner can create a schematic that can then be utilized to designate target areas where the ablation will be performed.
  • Regions of cardiac tissue can be mapped by a catheter to identify the abnormal electrical signals.
  • the same or different catheter can be used to perform ablation.
  • Some example catheters include a number of spines with electrodes positioned thereon. The electrodes are generally attached to the spines and secured in place by soldering, welding, or using an adhesive. Forming a spherical basket from the spines can be a difficult task. What is needed, therefore, are alternative devices and methods of forming a basket assembly that can help to reduce the time required for manufacturing the basket assembly and alternative basket assembly geometries in general.
  • a basket catheter having an end effector with multiple spines can be constructed with a combination of manufacturing techniques including at least two of the following techniques: individual spines, a loop with two spines, a cut sheet, and a cut tube.
  • a cut sheet or a cut tube can be formed to include a distal hub that has openings through which spines of one or more additional structures can pass through so that the distal hub joins distinct structures of the end effector. This provides several alternative manufacturing techniques compared to those presently used in basket catheters which rely on only one of the aforementioned manufacturing techniques.
  • An example end effector of a catheter can include an expandable support frame assembly and a plurality of electrodes.
  • the expandable support frame can include a first unitary structure and a second plurality of spines separate from each other and separate from the first unitary structure.
  • the first unitary structure can include a distal hub and a first plurality of spines extending from the distal hub of the first unitary structure.
  • the second plurality of spines can include respective distal portions that can be coupled to the distal hub of the first unitary structure.
  • Each respective spine of the first plurality of spines and the second plurality of spines can include a respective proximal end coupled together approximate a proximal end of the end effector.
  • Each electrodes of the plurality of electrodes can be coupled to a respective spine of the first plurality of spines and the second plurality of spines.
  • the first plurality of spines and the second plurality of spines can be configured to expand away from a longitudinal axis to collectively form a basket shape.
  • the spines of the first plurality of spines can be positioned in an alternating pattern with spines of the second plurality of spines.
  • the first plurality of spines can include 2, 3, 4, 5, or 6 spines.
  • the second plurality of spines can include 2, 3, 4, 5, or 6 spines.
  • At least a portion of the spines of the second plurality of spines can include a respective bend in a respective distal portion.
  • the respective bend can couple the respective distal portion to the distal hub.
  • the respective bend can be approximately 360°. Additionally, or alternatively, at least a portion of the spines of the second plurality of spines can be coupled to the distal hub with soldering, welding, or using an adhesive.
  • the distal hub can include a plurality of openings therethrough wherein respective distal portions of the second plurality of spines can be disposed through openings of the distal hub.
  • the expandable support frame assembly can include a first unitary structure and a second unitary structure separate from the first unitary structure.
  • the first unitary structure can include a distal hub and a first plurality of spines that extend from the distal hub.
  • the second unitary structure can include a second plurality of spines that extend through one or more openings of the distal hub.
  • Each spine of the first plurality of spines and the second plurality of spines can include a respective proximal end coupled together approximate a proximal end of the end effector.
  • Each of the plurality of electrodes can be coupled to a respective spine of the first plurality of spines and the second plurality of spines.
  • the first plurality of spines and the second plurality of spines can be configured to expand away from a longitudinal axis to collectively form a basket shape.
  • the first plurality of spines can be positioned in an alternating pattern with spines of the second plurality of spines.
  • the first plurality of spines can include 2, 3, 4, 5, or 6 spines and the second plurality of spines can include 2, 3, 4, 5, or 6 spines.
  • the first unitary structure can be constructed from a tube.
  • the second unitary structure can be constructed from a planar sheet.
  • the second unitary structure can include a central portion circumscribed by the distal hub.
  • the distal hub of the first unitary structure can be cylindrical.
  • the distal hub can include a plurality of openings such that each spine of the second plurality of spines extends from the central portion and through a respective opening of the plurality of openings of the distal hub.
  • the first unitary structure can be constructed from a planar sheet, and distal hub can be substantially planar.
  • the first unitary structure can be constructed from a tube, and the distal hub can be cylindrical.
  • An example method of constructing a medical probe can include the following steps performed in a variety of orders and with interleaving steps as understood by a person skilled in the art.
  • the method can include cutting a unitary structure to form a hub and a first plurality of spines extending from the hub; coupling a respective distal portion of each spine of a second plurality spines to the hub such that each spine of the second plurality of spines is unitary and separate from each other and the unitary structure; coupling a plurality of electrodes to spines of the first plurality of spines and the second plurality of spines; and affixing a respective proximal end of each spine of the first plurality of spines and the second plurality of spines at a distal end of an elongated shaft.
  • the method can further include configuring the first plurality of spines and the second plurality of spines to expand away from a longitudinal axis to collectively form a basket shape.
  • the method can further include positioning the first plurality of spines in an alternating pattern with the second plurality of spines.
  • the first plurality of spines and the second plurality of spines can include 2, 3, 4, 5, or 6 spines.
  • the method step of coupling the respective distal portion of each spine of the second plurality spines to the hub can further include bending the respective distal portion of one or more respective spines of the second plurality of spines about a portion of the hub.
  • the respective bend can be approximately 360°.
  • Another example method of constructing a medical probe can include the following steps performed in a variety of orders and with interleaving steps as understood by a person skilled in the art.
  • the method can include cutting a first unitary structure to form a hub and a first plurality of spines extending from the hub; cutting one or more openings in the hub; cutting a second unitary structure to form a central portion and a second plurality of spines extending from central portion; extending at least a portion of the second plurality of spines through the one or more openings in the hub; positioning the central portion centrally with respect to the hub; coupling a plurality of electrodes to spines of the first plurality of spines and the second plurality of spines; and affixing a respective proximal end of each spine of the first plurality of spines and the second plurality of spines at a distal end of an elongated shaft.
  • the method can further include configuring the first plurality of spines and the second plurality of spines to expand away from a longitudinal axis to collectively form a basket shape.
  • the method can further include positioning the first plurality of spines in an alternating pattern with the second plurality of spines.
  • the first plurality of spines and the second plurality of spines can include 2, 3, 4, 5, or 6 spines each.
  • the first unitary structure can include a tube.
  • the second unitary structure can include a planar sheet.
  • the spines of the end effectors of the catheters of the references in the Appendix may be modified to be constructed with a combination of manufacturing techniques including at least two of the following techniques: individual spines, a loop with two spines, a cut sheet, a loop with two spines, and a cut tube as understood by a person skilled in the art.
  • the illustrated support structures and spines herein may be modified to include compatible features of the support structures and spines described in the Appendix as understood by a person skilled in the art.
  • FIG. 2 is an illustration of a first example end effector of the catheter 14 including an expandable basket assembly 68 including a first example expandable support frame assembly 100 and electrodes 26 coupled to spines 101, 111, 102, 112, 103, 113 of the first example expandable support frame assembly 100.
  • the first example expandable support frame assembly 100 includes a first unitary structure 110 and a second plurality of spines 101, 102, 103 that are separate from each other and separate from the first unitary structure 110.
  • the first unitary structure 110 includes a distal hub 117 and first plurality of spines 111, 112, 113 that extend from the distal hub 117.
  • the distal hub 117 is disposed at a distal end 36 of the end effector 100.
  • each spine 101, 111, 102, 112, 103, 113 are coupled together within the shaft 84 near a proximal end of the end effector 100 and a distal end of the shaft 84.
  • the catheter 14 can include a spine retention hub 90 that extends longitudinally through the distal end of the tubular shaft 84.
  • Spine retention hub 90 can include a cylindrical member can be configured to affix proximal ends of the spines 101, 111, 102, 112, 103, 113 within the shaft 84.
  • the spine retention hub 90 can include a distal portion 98 within the basket that may include irrigation openings and/or an electrode.
  • FIGs. 3A through 3D illustrate a second example support frame assembly 200.
  • the second example support frame assembly 200 can be used in place of the first example support frame assembly 100 in FIG. 2 to form a catheter similar to the catheter 14 illustrated in FIG. 1 .
  • FIG. 3A illustrates an individual spine 201 having a proximal end 204 and a bend 202 near a distal spine end 207 of the spine 201.
  • the bend 202 is approximately 360°, although an angle less than 360° (e.g. between 180° and 360°) may be sufficient, or a kink (similar to kink 902 in FIG. 9 ) may be used in place of bend 202.
  • FIG. 3C illustrates four individual spines 201 ( FIG. 3A ) coupled to the planar sheet 210 ( FIG. 3B ).
  • the spines 211 of the planar sheet 210 are in an alternating arrangement with the individual spines 201.
  • the spine distal end 207 is inserted in a respective opening 212, and the individual spine 201 is aligned so that the spine distal end 207 is positioned proximally along the individual spine 201 in relation to the bend 202.
  • the individual spine 201 can be pre-bent, and the individual spine 201 can be rotated about the bend 202 as the individual spine 201 is attached to the distal hub 217.
  • the individual spine 201 can be bent after the spine distal end 207 is inserted into a respective opening 212, thereby forming bend 202.
  • first example support frame assembly 100 illustrated in FIG. 2 includes a total of six spines while the second example support frame assembly 200 illustrated in FIGs. 3A through 3D include a total of eight spines.
  • the second example support frame assembly 200 can be modified to include six spine; and conversely, the first example support frame assembly 100 can be modified to include eight spines.
  • the individual spines 101, 102, 103 of the first example support frame assembly 100 can be attached to the distal hub 117 similar to how the individual spines 201 are attached to the distal hub 217 as illustrated in FIGs. 3A through 3D .
  • the bend 202 can be configured to rotate through the respective opening 212, which can be advantageous as it can facilitate movement of the individual spines 201 between a collapsed configuration during delivery and a basket shape when deployed.
  • the respective bend of the individual spines 201 can be approximately 360°, however the degree of curvature for the respective bend of the individual spines 201 is not so limited. It should also be appreciated that the degree of curvature for the respective bend between each of the individual spines 201 can vary to allow for enduring couplings with various support structures.
  • FIGs. 4A through 4C illustrate a third example support frame assembly 300.
  • the third example support frame assembly 300 can be used in place of the first example support frame assembly 100 in FIG. 2 to form a catheter similar to the catheter 14 illustrated in FIG. 1 .
  • FIG. 4A illustrates an individual spine 301 having a proximal end 304 and a bend 302 near a distal spine end 307 of the spine 301.
  • the individual spine 301 illustrated in FIG. 4A is configured similarly to the individual spine 201 illustrated in FIG. 3A .
  • the bend 302 is approximately 360°, although an angle less than 360° (e.g. between 180° and 360°) may be sufficient, or a kink (similar to kink 902 in FIG. 9 ) may be used in place of bend 302.
  • FIGs. 8A, 8B, 8C, and 8D are illustrations of a fifth example support frame assembly 700.
  • the fifth example support frame assembly 700 can be used in place of the first example support frame assembly 100 in FIG. 2 to form a catheter similar to the catheter 14 illustrated in FIG. 1 .

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  • Heart & Thoracic Surgery (AREA)
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EP23219842.4A 2022-12-29 2023-12-22 Korbkatheter mit einer kombination aus wirbelsäulenstrukturen Pending EP4393434A1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202263477644P 2022-12-29 2022-12-29
US202363482697P 2023-02-01 2023-02-01
US18/507,321 US20240216048A1 (en) 2022-12-29 2023-11-13 Basket catheter with combination of spine structures

Publications (1)

Publication Number Publication Date
EP4393434A1 true EP4393434A1 (de) 2024-07-03

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EP23219842.4A Pending EP4393434A1 (de) 2022-12-29 2023-12-22 Korbkatheter mit einer kombination aus wirbelsäulenstrukturen

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EP (1) EP4393434A1 (de)
JP (1) JP2024096081A (de)
IL (1) IL309657A (de)

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EP4470490A3 (de) * 2023-06-02 2025-02-12 Biosense Webster (Israel) Ltd. Distale endfunktion eines korbkatheters

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